Recall Z-2231-2011 ยท GGK Products, Red-Cell Lysing Products
Beckman Coulter Inc.
COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable.
| Date | May 20, 2011 (initiated Apr 8, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171. |
| Root cause | Other |
| Action | Beckman Coulter initiated a Product Corrective Action (PCA) letter on April 8, 2011, with attached PCA Response Form to all customers who purchased the COULTER Ac"T" 5diff Fix Reagent. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discard the product according to their laboratory safety procedures and use the attached response form to request replacement product. All flagged results should be reviewed as outlined in the Instructions for Use manual and your laboratory protocol. A retrospective review of |
| Quantity | 4662 units total (2278 in US) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Botswana, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Guyana, Italy, Japan, Kenya, Mexico, Morocco, Namibia, Netherlands, Nigeria, Philippines, Puerto Rico, Russian Federation, Slovaki |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.